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What is an FDA OTC Monograph?
- Daniel Jiménez
- May 8
- 2 min read
An OTC (Over-the-Counter) Monograph from the U.S. Food and Drug Administration (FDA) is the set of technical and legal requirements that allow an over-the-counter drug to be marketed without having to submit an individual New Drug Application (NDA).
In practice, it acts as a "cookbook" for the industry: if the product complies exactly with the applicable monograph, the FDA considers it generally recognized as safe and effective (GRASE) and can go directly to market.
Table of contents
Contents of a monograph
Each monograph is published by therapeutic category (analgesics, antacids, sunscreens, etc.) and details:
Permitted active ingredients and their maximum/minimum concentrations.
Indications for use (for what ailment or symptom it can be advertised).
Routes of administration and dosage .
Required formulations and quality tests .
Legends and labeling format (Drug Facts) that must appear literally on the package.
Regulatory pathways for an OTC drug
Option | Summary | When to use |
OTC Monograph | Dependent on full compliance with the monograph (without prior FDA review). | Products whose formulas and labeling fit 100% into an existing category. |
NDA / ANDA | Individual review by the FDA (similar to a prescription drug). | New ingredients, dosages, or presentations that do not fit into a monograph. |
CARES Act Reform (2020)
On March 27, 2020, the CARES Act added Section 505G to the FD&C Act and modernized the monograph system:
It replaced the slow regulatory process with Administrative Orders (proposed, final, and interim).
Launched the OMUFA fee program, which funds the review and streamlines the timeline.
It gave the FDA the power to issue expedited orders when imminent safety risks arise.
Advantages for your company
Faster market entry : without waiting for an NDA approval.
Lower regulatory costs : the “recipe” already defines what is necessary to demonstrate safety and efficacy.
Transparency and predictability : All requirements are public and updated by the FDA.
Flexibility : If you need to innovate outside of the monograph, you can always opt for the NDA route.
Complying with the appropriate OTC Monograph is the most efficient way to launch OTC medications in the U.S. Knowing its scope and limitations will allow your company to plan development, labeling, and market strategy from day one.
